Cardiola receives EU approval for home cardiac counterpulsation system

27 May 2009

Cardiola AG has received CE Mark recertification to market its m.pulse system for at-home use to treat chronic heart failure (CHF), the most frequent cause of hospitalization in persons over 65.

Current treatments for CHF, including drugs, implantable defibrillators/pumps and heart transplantation, have significant risks and side effects. Cardiola’s m.pulse system, based on muscular counterpulsation (MCP) technology, has been recertified in Europe for treating CHF as a nonsurgical, at-home therapy.

The phone-sized m.pulse is attached to the patient's belt for about 45 minutes per treatment. It is synchronized to the patient's cardiac cycle to stimulate the muscles of the calves and thighs to make them contract counter to the heart’s beating.

This well-established counterpulsation action results in increased blood flow to the heart muscle while decreasing the heart’s workload. Counterpulsation was previously only available in a clinical setting.

“Clinical evidence, published in peer-reviewed medical journals, has demonstrated that MCP — the proprietary technology platform of our patented m.pulse device — facilitates timely and effective therapy, improving outcomes for CHF patients,” said Christof Lenz, Cardiola’s CEO and former Global Innovation Manager at Siemens Medical.

“We are extremely pleased that our m.pulse system has been cleared for marketing in Europe as a well-validated, affordable and non-surgical treatment alternative that patients themselves can perform in their own home.”

Chronic Heart Failure is among the world’s most prevalent diseases and the cause of numerous other serious clinical disorders. Approximately 17 million people currently suffer from CHF in Europe, the US and Japan. Some six million of these patients are classified as NYHA (New York Heart Assn.) classes II and III with systolic dysfunction, the primary patient population for m.pulse.

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